harm likelihood value expression
IRI: https://spec.industrialontologies.org/ontology/construct/HarmLikelihoodValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › harm likelihood value expression
Definition
value expression that represents the assessed likelihood that a specified harm will occur in relation to one or more specified potential sources of harm
Examples
- likelihood score 2 for patient harm from reduced product availability caused by batch rejection; likelihood category ‘remote’ for hypoxic injury during helium refill after oxygen monitoring controls are implemented
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
HarmLikelihoodValueExpression(x) → ValueExpression(x) ∧ ∃m∃h(HarmSpecification(m) ∧ continuantPartOfAtAllTimes(x,m))
Semi-Formal Natural Language Axioms
if x is a ‘harm likelihood value expression’ then x is a ‘value expression’ that is ‘continuant part of at all times’ some ‘harm specification’
Description Logic
constr:HarmLikelihoodValueExpression ⊑ constr:ValueExpression
constr:HarmLikelihoodValueExpression ⊑ ∃ bfo:continuant_part_of_at_all_times .constr:HarmSpecification
SubClassOf: constr:ValueExpression
SubClassOf: bfo:continuant_part_of_at_all_times some constr:HarmSpecification